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Omron R7 (HEM-637-E7)

Device Name:R7
Device Model:HEM-637-E7
Manufacturer:Sole: Omron Corporation, Kyoto Head Office, Shiokoji Horikawa, Shimogyo ku, Kyoto 600-8530, JAPAN.
Measuring functions:Blood pressure
Primary Client Use:Intended for self-measurement and home use
Measurement Site:Wrist
Measurement Occurrence:Single measurements only
Availability:Discontinued but still available
Description: The Omron R7 (HEM-637-E7) is a clinically validated automatic blood pressure monitor. Measurements are taken from the wrist and it is intended for self-measurement and home use. This device has been discontinued by the manufacturer but may be available through certain outlets.
Assessment:

The technology used in the Omron R7 (HEM-637-E7), to measure blood pressure, has been compared to a clinically validated device but not according to a protocol compliant with (EU) 2017/745 and MEDDEV 2.7/1 rev 4.

Accuracy AssessmentRecommendationBasis
MedavalNoneAlthough equivalence to another device is claimed, this has not been tested to MDR requirements.

Device Family:Boots 65-90-412B, Omron 637IT (HEM-637IT-E)B,D, Omron R2 (HEM-6113-E)B, Omron R2 (HEM-6113-FR)B, Omron R6 (HEM-6000-E7)B,D, Omron R6 (HEM-6052-2)B,D, Omron R7 (HEM-637-E2)B, Omron R7 (HEM-637-E7)D (B BIHS Derivative, D DET Equivalence)
Relevant Publications

Ware A, Stevens R, Selwood M, Fleming S. Accuracy of blood pressure monitors available in high street pharmacies. Blood Press Monit. 2016 Feb;21(1):59-61. doi: 10.1097/MBP.0000000000000151. PMID: 26427055.

Measurements from the Omron R7 (HEM-637-E7) are compared to those from the Omron BPM tester PA-350, though not in a formal validation.

Halfon M, Wuerzner G, Marques-Vidal P, Taffe P, Vaucher J, Waeber B, Liaudet L, Ltaief Z, Popov M, Waeber G. Use of oscillometric devices in atrial fibrillation: a comparison of three devices and invasive blood pressure measurement. Blood Press. 2018 Feb;27(1):48-55. Epub: 2017 Sep 28. doi: 10.1080/08037051.2017.1383852. PMID: 28958152.

Measurements from the Omron R7 (HEM-637-E7) are compared to those from the Microlife WatchBP Home (BP 3MX1-1) and the Omron HEM-907 (HEM-907-E7) in atrial fibrillation, though not in a formal validation.

Validation Publications for Equivalent Devices

Note: This is a provisional list, as equivalence according to EU Regulation 2017/745 (e.g. MEDDEV 2.7/1 rev 4) is not proven. Accordingly, these publications are not used in the assessment of star-ratings.

Omron 637IT (HEM-637IT-E)

Altunkan S, Altunkan E. Validation of the Omron 637IT wrist blood pressure measuring device with a position sensor according to the International Protocol in the elderly. Blood Press Monit. 2006 Apr;11(2):97-102. PMID: 16534412.

ESH-IP:2002 - Pass Elderly (Age>65)

Altunkan S, OztaƟ K, Altunkan E. Validation of the Omron 637IT wrist blood pressure measuring device with a position sensor according to the International Protocol in adults and obese adults. Blood Press Monit. 2006 Apr;11(2):79-85. PMID: 16534409.

ESH-IP:2002 - Pass General population

Topouchian JA, El Assaad MA, Orobinskaia LV, El Feghali RN, Asmar RG. Validation of two automatic devices for self-measurement of blood pressure according to the International Protocol of the European Society of Hypertension: the Omron M6 (HEM-7001-E) and the Omron R7 (HEM 637-IT). Blood Press Monit. 2006 Jun;11(3):165-71. PMID: 16702826.

ESH-IP:2002 - Pass General population

Omron R2 (HEM-6113-E)

Topouchian J, Agnoletti D, Blacher J, Youssef A, Ibanez I, Khabouth J, Khawaja S, Beaino L, Asmar R. Validation of four automatic devices for self-measurement of blood pressure according to the international protocol of the European Society of Hypertension. Vasc Health Risk Manag. 2011;7:709-17. Epub: 2011 Nov 30. doi: 10.2147/VHRM.S27193. PMID: 22174581. Available from: PMC3237100.

ESH-IP:2002 - Pass General population